® xPONENT 3.1 Rev.
© Luminex Corporation, 2012. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any language or computer language, in any form or by any means without prior express, written consent of Luminex Corporation. For In Vitro Diagnostic Use Only. LUMINEX CORPORATION 12212 Technology Boulevard Austin, Texas 78727-6115 U.S.A. Voice: (512) 219-8020 Fax: (512) 219-5195 WMDE Bergerweg 18 6085 AT Horn The Netherlands xPONENT 3.1 Rev.
End-User License Agreement (EULA) for Luminex® xPONENT® Software This Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an individual or a single entity, also referred herein as “you”) the end-user and Luminex Corporation (“Luminex”) regarding the use of the xPONENT software product provided to you above, which includes computer SOFTWARE and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE”).
SOFTWARE on additional computers, as agreed to in writing with Luminex or its authorized reseller, for purposes of performing ancillary tasks (i.e. preparing templates/ protocols, performing further analysis or re-running previous data), provided such computers are at a single location and are NOT connected with a Luminex instrument.
be protected by applicable copyright or other intellectual property laws and treaties. This EULA grants you no rights to use such content. 7. EXPORT RESTRICTIONS. You agree that you will not export or re-export the SOFTWARE to any country, person, entity, or end-user subject to U.S.A. export restrictions. You hereby warrant no state or federal agency has suspended, revoked, or denied your export privileges. 8. NO WARRANTY. THE SOFTWARE IS LICENSED "AS IS." ANY USE OF THE SOFTWARE IS AT YOUR OWN RISK.
xPONENT® 3.1 Rev.
Table of Contents Chapter 1 Introduction ........................................................................................................1 Software Packages ......................................................................................................................................1 About this Guide ..........................................................................................................................................1 Warnings, Notes and Symbols .........................
Admin .........................................................................................................................................................56 System Setup Tab ...............................................................................................................................57 Group Setup Tab .................................................................................................................................58 User Setup Tab ........................................
Performing System Maintenance ...............................................................................................................89 Performing Individual Maintenance Commands ..................................................................................89 Perform System Calibration ................................................................................................................89 Manage Maintenance Routines ......................................................................
xPONENT® 3.1 Rev.
Chapter 1: Introduction The Luminex system was developed to improve workflow and efficiency in the clinical laboratory and in research and development. End users in the laboratory must run microtiter plates using xMAP®-based assay kits developed for use with xMAP technology. Software Packages xPONENT® software has different levels of functionality: • Allows you to perform analysis from IVD protocols and batches, review and print reports, and perform Luminex system maintenance.
This guide is formatted as a PDF, and can be printed. However, the guide is best viewed online due to the bookmarks and hypertext included in the text. This guide may be updated periodically. To ensure that you have a current version, access http://www.luminexcorp.com/Downloads/index.htm. The most recent version of this guide, as well as all translations of this guide, are available for download at that URL.
TABLE 2. Symbols Continued Manufacturer In-vitro Diagnostic Device Conformité Europeénne (European Union Conformity) General Guidelines Modifying or deleting Luminex®xPONENT® system files may cause degradation to system performance. You can repair modified or deleted xPONENT system files by uninstalling and re-installing the xPONENT software. Use of unauthorized third-party software with xPONENT software may result in corruption or failure of the xPONENT software.
xMAP beads are hydrophobic in the aqueous medium provided and will settle if left undisturbed. Resuspend prior to dispensing. Do not use this product with strong organic solvents. For information on specific compatibility, visit the Luminex Technical Support website at Luminex Technical Support. Safety Precautions All samples should be regarded as potentially contaminated and treated as infectious.
set. Since each bead is analyzed individually, even when the sets are mixed in a multiplex assay they can still be distinguished by their emission signals. The fluorescence signal of reporter molecules bound to the surface of each bead set is measured and used to determine the result of each assay in a multiplex. Again, since each bead is analyzed individually, reporter signals for each bead set can be accurately quantified.
Reagents Formulated reagents must be free of particulates other than xMAP beads. Do not dilute xMAP calibrators or verifiers. Plates When using uncovered plates, use black opaque plates, if possible, to reduce photobleaching. For heated assays, use CoStar® Thermowell® 96-well, thin-wall polycarbonate, model P plates. For non-heated assays, select a 96-well plate with an overall height no greater than 0.75 inches (19 mm). Follow the xMAP based IVD kit instructions for use.
Chapter 2: Touring the Software This chapter explores each section of the software and its functionality. For information about using the software, see Using the Software. This chapter describes default views. Please note that views can be changed and functionality can be disabled by the xPONENT system administrator. Log In To log in, type your user ID at the System Login tab. If you are using the secure version of the software, type your password. Once you have logged in, the Home page opens.
Exit After you log out, click Exit, then Yes to exit the software completely. Screen Elements The following section details the screen elements and the common terms used in this manual to describe them. FIGURE 1. Screen Elements 1 Page 2 Tab 3 Right-click Menu • Page - The main elements at the top of the window are “Pages”. Click a page to go to that section of the software. All but the Home, and in some cases the Admin, page can be moved or deleted.
• Tab - The elements on the left side of the window are “Tabs”. Click a tab to go to that section. Some tabs require you to go in order, and will not let you click a tab further down without performing a task on the current tab. • Right-Click Menu - Certain sections of the software such as tables, lists, and text boxes have right-click option menus. Menus are different depending upon the item you rightclicked. • Print All - Prints all sections or cells of the item.
NOTE: A yellow Check Calibration button is visible in the command display if the calibration or verification command has failed, when any verification is not current, or when the calibration or verification was performed prior to the calibration expiration setting. • Progress - Displays a bar graph showing the progress of the current command or routine; if the command or routine is finished, it displays a full progress bar and the command status as Complete.
FIGURE 3. Home Page Return to the Home page at any time by clicking Home in the Navigation toolbar. This page contains the following: • Click to Create a new Batch using the highlighted Protocol below - Creates a new batch using a selected protocol from the Installed Protocols list. For more information about creating a batch from an existing protocol, see Create a New Batch from an Existing Protocol. • Installed Protocols - Displays a list of protocols.
• Probe and Heater - Opens the Probe and Heater tab on the Maintenance page. For more information about this tab, see Probe and Heater Tab . • Sys Info - Opens the System Info tab of the Maintenance page. For more information, see System Info Tab. • Reports - Opens the Reports tab of the Results page. For more information, see Reports Tab. Samples Use this page to create new samples, view the details of a sample list, or to create a new batch.
• Sample Lists - Contains a list of protocols, including the version number and the number of samples associated with each protocol. • Details - Opens the Edit Samples tab to view or edit sample details for the selected protocol. • Create Batch - Opens the Protocol tab to create a batch. Create Sample Tab Use this tab to type and view sample information. FIGURE 5. Create Sample Tab This tab contains the following: • Protocol - Displays the protocol selected in the Samples tab.
• New - Creates a new sample. • Edit - Edits a highlighted sample. • Undo - Reopens the Create Sample tab without saving any changes made using the Edit or New buttons. • Save - Saves changes made to the Sample list. • Close - Returns to the Samples tab. Batches Use the Batches page to create and run a new batch from an existing protocol or a new multi-batch. This page contains the following tabs: • Protocol - Displays when the Create a New Batch from an existing Protocol button is clicked.
FIGURE 6. Batch Plate Layout Report • Import - Imports a batch. • Export - Exports a batch. • Delete - Deletes a batch. • Edit - Edits a batch. • Run - Runs a batch. Create a New Batch from an existing Protocol Creates a New Batch from an existing protocol. The Protocol tab opens. Protocol Tab Use this tab to name a batch, type a description, select a protocol, and view active reagents.
FIGURE 7. Protocol Tab This tab contains the following: Batch Name/Description - Contains the protocol name, version, manufacturer, and creation date for each protocol. Select a Protocol - Contains the protocol name, version, manufacturer, and creation date for each protocol. Active Reagents - Displays assay and control lots/kits associated with the selected protocol.
FIGURE 8. Stds & Ctrls Tab This tab contains the following: Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The dialog box displays the Std/Ctrl Kit Lot #, Std/Ctrl Kit Name, Expiration, and Manufacturer for the kit. Select a Std/Ctrl kit from the list and then clickOK to close the dialog box. The kit information will display in the boxes to the right of the Apply Std/Ctrl Kit button. The selected kit must be associated with the same analyte names.
• 1/2 Log - Creates a 1:3.16 dilution, or half of each 1:10 (Log) from each previous iteration. • Alternatively, type a number for your own dilution factor. • Apply Dilution - Applies the dilution selected in the Dilution list. NOTE: Click a column header to resort the display. NOTE: Click the Reagent column header to resort the order from the highest number standard to standard number one. This is useful for applying dilutions in which the last standard is the highest standard.
FIGURE 9. Plate Layout Tab This tab contains the following: • Plate Image - This is a representation of the plate. Each well appears as a circle on the grid. Well commands appear in the appropriate circles as you assign them to wells on the plate. • Command Sequence - Contains the command sequence for the active plate. The list includes all active wells, the type of command (Unknown, Standard, Control, Background, or assigned maintenance command), ID, and dilution factor.
entire column or row, or simply click and highlight different wells and then click a command below to assign that command to all the highlighted wells. • Unknown (U): Yellow • Background (B): Purple • Control (C): Red • Standard (S): Green The Delete and Start at Well commands are also available to assign as well commands. Delete removes the well command for the selected well. The Start at Well command enables you to begin acquisition at a well other than A1.
Off Plate Area - Highlight a command and click a either a Reservoir in the Off Plate Area to select a location for the command. Save Prtcl - Opens the Save Protocol dialog box to save the protocol and or kit. FIGURE 10. Save Protocol Dialog Box • Select Save Protocol and/or Save Std/Ctrl Kit to save the protocol and/or kit. • Type information in the following boxes and click Save to save the protocol or kit.
Run Batch - Runs the batch and opens the Current Batch tab, where you can monitor the batch as it runs. FIGURE 11. Create a New Multibatch Use this button to add or remove pending batches to the multi-batch set up and to run a multi-batch. A multi-batch is composed of one or more pending batches which, together, will fit on one plate. Use the multi-batch feature to conserve plates. NOTE: You cannot add a batch that forces multiple plates to a multi-batch operation.
FIGURE 12. New Multibatch Tab This tab contains the following: Multi-Batch name - Use this field to create a name for new multi-batches you want to save. Select Pending Batch - Contains a list of all pending batches. The list includes name, protocol, protocol version, date, and status information for each pending batch. Select the batch you want to add to the plate. Click OK. A plate layout diagram automatically populates the wells for the batch.
FIGURE 13. Select Pending Batch dialog box Plate layout - Depicts where batches are located on the plate. FIGURE 14. New Multibatch tab with plate layout displayed Multi-Batch - lists pending batches selected for the multi-batch. The list includes name and "Start at" well. xPONENT® 3.1 Rev.
Plate Layout - Opens the Multibatch Report dialog box that contains: • Page - Use these arrows to scroll through the report pages. • Zoom - Select from the list to change the report magnification. • Print - Prints report. • Save - Saves report. • Close - Closes report dialog box. The Multibatch Plate Layout Report includes the multibatch plate layout, command number, plate location, command type, sample ID and dilution. The report is date and time stamped. FIGURE 15.
NOTE: When a batch is saved to a multibatch, you cannot edit or delete it unless it is removed from the multibatch. Run - Runs the batch. Results Once data is collected in a batch, observation and analysis take place in the Results page.
FIGURE 16. Current Batch Tab Statistic - To view a particular statistic for analytes in a batch, select one of the following: • Median - The point in a data set where there are as many values occurring above it as there are below it. • Test Result - The calculated analysis value for quantitative or qualitative assays derived from standards with known values. • Range - A semi-quantitative result for a particular numerical result falling between a predefined set of values such as “Normal” or “Negative”.
Trimmed%CV of microspheres - The measure of relative dispersion within the trimmed distribution. • Trimmed %CV = 100 x Trimmed Std Dev / Trimmed Mean • Trimmed Standard Deviation - The measure of dispersion within the trimmed distribution. • Trimmed Std Dev = ( (Nt Σxi 2 - Σxi)2) / Nt (Nt -1) )1/2 • Trimmed Peak • % CV of Replicates - The measure of relative dispersion within the distribution of results for replicate samples.
Click the maximize button to maximize the graph to fill the whole window. In the maximized view, use the sliders to zoom in or zoom out. To return to the standard view, click the minimize button. If the histogram or dot plot display have been changed to another view (e.g. Progress, Well Report), click Default to return to the default histogram and dot plot displays. Histogram - The default location of the histogram is the lower left section of the Current Batch tab.
Progress - Click to display real-time progress of the well acquisition. Analyte counts are displayed in a dynamic bar graph as they are acquired. The scroll bar at the bottom of the Progress display scrolls through the analyte list. • Maximize - Maximizes the Progress display to fill the window. • Zoom - Enable a closer look at the analyte progress. • Save Image - Opens a Save As dialog box to save a screen capture. • Default - Returns to the histogram and dot plot display.
Filter - Opens the Filter Setup dialog box. FIGURE 18. Filter Setup Dialog Box This dialog box lets you choose the saved batches you want to display in the Completed Batches list based on options you select or clear in the following check boxes: • Batch Name • Protocol • Batch Status • Lot ID • Kit ID • Analyte • Sample ID • First Name • Last Name • User ID • Date Reset - Clears all check boxes. OK - Closes the dialog box and cancels any changes you made.
FIGURE 19. Batch Plate Layout Report Approve - Opens the Batch Approval Confirmation dialog box to approve the selected batch. Only approved batches can be transmitted to the LIS. If your software is licensed for LIS use, you can transmit batches to the LIS from the Sample Results tab. Once you have approved a batch, the status of the batch changes to Approved in the Completed Batches list. Exp Results - Opens the Save As dialog box to choose an export destination for the .
Results Tab FIGURE 20. Results Tab The Results tab has the same Save Image, Progress, and Well Report buttons as the Current Batch tab. For more information about these buttons, see Current Batch Tab. The following buttons are added to the Results tab: • Formula - Opens the Change Analysis dialog box with a list of analytes used in the batch. Click an analyte to open the Analysis Settings dialog box from which you can select a new analysis setting for the analyte.
Settings Tab Use this tab to view the acquisition parameters of the selected saved batch and print the batch settings report. FIGURE 21. Settings Tab Page - Scrolls through the Batch Settings report. Save - Opens the Save As dialog box to save the Batch Settings report. Select a location and click OK to save the file. The default save type is a .pdf file. Print - Prints the report. Close - Returns to the Saved Batches tab.
FIGURE 22. Log Tab This tab displays the following information about each activity: • Date • Message • Code Log entries display yellow if a well was acquired but there was a possible problem. They display red if a problem occurred during the acquisition. Print - Prints the log. Export - Opens the Save As dialog box to save the batch log file. Select a location and click Save. Close - Reopens the Saved Batches tab. Sample Details Tab Use this tab to view sample results.
FIGURE 23. Sample Details Tab Arrows - Scrolls through the sample details. Transmit - For systems configured for LIS transmission, select a single analyte or the entire sample and click Transmit to send the results. Close - Reopens the Saved Batches tab. LIS Results Tab This tab displays saved batches containing LIS samples. xPONENT® 3.1 Rev.
FIGURE 24. LIS Results Tab Filter - Opens the Filter Setup dialog box. Clear - Click to turn off the filter. Completed Samples - Displays Name, Protocol, Sample Count, Date, Status, and User information for each batch displayed in this list. Transmit - Transmits a batch to an LIS if xPONENT is connected to one. Details - Opens the Sample Details tab to view sample results. Reports Tab Use this tab to view, generate, and print reports.
FIGURE 25. Reports Tab Report and Type lists. Choose a report from one of the following categories: • Batch Reports - A list of batches appears below the Type list. The list includes Name, Protocol, Protocol Version, Date, Status, and User information. Select a protocol and then click Generate to generate the report. • Calibration and Verification Reports- Displays a list of calibrations and verifications.
System Log Reports - Displays a list of system log reports. Choose from the following selections: • All • Maintenance • Security • Warning and Errors Select a system log report, a date from the Date list, and click Generate to generate the report. Advanced Reports - Enables a single option, User Report, in the list. Click Generate to generate the report. Protocols The Protocols page enables you to add standards and controls.
FIGURE 26. Protocols Tab This tab contains the following: • Installed Protocols - Displays installed protocols. The list includes Name, Version, Manufacturer, and Date information for each protocol. • New Std/Ctrl - Opens the Std/Ctrl Details tab. For more information, see Stds and Ctrls Details Tab • Plate Layout - Opens the Report dialog box, which includes the Plate Layout Report. For more information see Saved Batches Tab. xPONENT® 3.1 Rev.
FIGURE 27. Protocols Plate Layout Report Delete - Opens the Delete Protocol dialog box to delete a protocol selected in the Installed Protocol list. Click Yes to delete the selected protocol. Import - Opens the Open dialog box to select a protocol (.lxt file) to import. Navigate to the protocol file you wish to import and click Open. Export - Opens the Save As dialog box to export a selected protocol. Choose an export destination and name, and click Save.
FIGURE 28. Stds & Ctrls Tab This tab contains the following: Create New Std/Ctrl Lots - Opens the Std/Ctrl Details tab to create a new lot or kit. For more information, see Stds and Ctrls Details Tab. Installed Kits And Lots - Displays information about the kits and lots currently installed on the system. • Show - Click either Std/Ctrl Kits Only or All Lots to choose what to display. • Group lots from the same Std/Ctrl Kit together - Select to group lots from the same kit together.
Select Std/Ctrl Kits Only in the Show selections to display the following information about the installed Std/Ctrl Kits: • Std/Ctrl Kit # • Std/Ctrl Kit Name • Expiration • Manufacturer • Created with Protocol • Version Delete - Deletes a selected lot. The Delete Lot(s) Confirmation dialog box opens. Click Yes to delete the lot. Edit - Opens the Std/Ctrl Details tab to edit the lot information. Export - Opens the Save As dialog box to export the selected lot.
Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The dialog box displays the Std/Ctrl Kit Lot #, Std/Ctrl Kit Name, Expiration, and Manufacturer for the kit. Select a Std/Ctrl kit from the list and then click OK to close the dialog box. The kit information will display in the boxes to the right of the Apply Std/Ctrl Kit button. The selected kit must be associated with the same analyte names.
• Auto Maint • Lot Management • Cmds & Routines • Probe & Heater • System Info • System Status • Schedule • Support Utility Auto Maint Tab This tab contains routines to initialize, verify, and maintain the analyzer. FIGURE 30. Auto Maint Tab Automated Maintenance Options - Provides buttons for commonly used maintenance routines for the machine. Select from the following: • System Initialization - Select this routine to initialize the system.
The commands for these routines display in the command list below the buttons. Command - This list is used to view the name of the current command, its well location, its status, and information about the command. Only the current commands appear in the box. Reagents - Displays the reagents and well locations necessary for the selected routine. You can select kits for the routines from the Calibration Kit and Performance Verification Kit lists.
• Performance Verification Kit - Select a performance verification kit from this list. Details of the selected kit display in the Lot Type, Active Lot Number, and Expiration Date fields. • Delete Kit - These buttons delete the selected calibration or performance verification kit. • Active Lot Number - Select an active lot number for the selected reagent from this list. Lot Details - Displays lot information for the selected reagent in the Active Reagents section.
FIGURE 32. Maintenance Commands and Routines Tab Routine Name - This list of pre-set routines and commands can be used for system maintenance. Some of these commands are also available on the Auto Maint tab. Additionally, you can create routines on this tab, which display in the Routine Name list once you save the routine. To create a routine, start with None and add the desired commands. You can also modify a Luminex routine and save it as a new routine.
• Soak - Prevents salt crystals from forming in the probe due to air exposure. Soaking the probe replaces sheath fluid in the probe with water. You should perform the soak function at the end of each day. The system uses at least 250 µL of distilled water. • CAL1 - Calibrates DD, CL1, and CL2 for original non-magnetic xMAP beads. • CON1 - Verifies DD, CL1, and CL2 for original non-magnetic xMAP beads.
Command Sequence - When you select a routine, the individual commands in the routine appear in order in the Command Sequence list. The list includes the name of each command, location, status, and any additional information. Clear - Clears the highlighted command in the Command Sequence list. Clear All - Clears all commands in the Command Sequence list. Report - Opens the Reports tab with the Calibration Summary selected in the Report: list. Click Generate to view the selected report.
FIGURE 33. Probe and Heater Tab Move Probe Down - Moves the probe down in the specified well(s). Plate Type - Defines the selection of either a 96-well plate or an Automated Maintenance plate. Plate Image - Identifies the location to be used to adjust the probe height. Clicking a well selects it and marks it with a blue pin. Plate Heater - Sets the temperature of the plate to the number typed in the Set Temperature box.
FIGURE 34. System Info Tab This tab contains the following information: • Software • Version • Operating System • Licensing • Instrument Type • Serial Number • Firmware Version • XY Serial Number • XY Firmware Version • XYP Heater Temperature • Air Pressure • Sheath Pressure • Calibration Status • Last CAL1 Calibration • Last MagCAL1 Calibration • Last CAL2 Calibration • Last CON1 Verification • Last MagCON1 Verification xPONENT® 3.1 Rev.
• Last CON2 Verification • Delta Calibration Temp • System Temperature • DD Temperature • CL1 Temperature • CL2 Temperature • CL1 Voltage • CL2 Voltage • DD Voltage RP1 Voltage - Items in this list relating to CAL/Verification, CON calibration, and controls have one of the following states: • Passed - Indicates that the process completed successfully. • Failed - Indicates that the process was not completed successfully. Failed items appear in red. • Not Current - Indicates that verifiers are not current.
FIGURE 35. System Status Tab This tab contains the following: Search By Log Type - Filters the type of log information. Select All, Maintenance, Security, or Warnings and Errors. Search By Log Date - Enables using a date range to display a log of system activities. Advanced - Displays the following added information in the system log: • Log Type • User ID • Error Level Log - Displays a list of information for each system process.
Schedule Tab Use this tab to view reminders for scheduled maintenance due to be performed on the analyzer. FIGURE 36. The Schedule Tab The Reminders section displays Subject, Reminder, Next Alert Date, Alert Time, and Notes. This schedule can be changed using the Schedule tab of the Admin page. For more information, see Schedule Tab Support Utility Tab Use this tab to type information that will be useful in the event you need to contact Luminex Technical Support.
FIGURE 37. Support Utility Tab This tab contains the following: Name, Phone, Company, and Email - Type your information in these boxes so that Luminex Technical Support can contact you. Clear - Clears all information in the Name, Phone, Company, Email, and Comment boxes. Comment - Type any comments in this box. Include Batch info - Includes batch information from a selected batch in the Support Utility.zip export folder. Select Batch - Displays a list of all batches.
• User Setup • Batch Options • Alert Options • CSV Options • Archive • Licensing • Schedule • Report Options System Setup Tab Use this tab to configure system settings. FIGURE 38. System Setup Tab Application Settings These settings change some of the basic ways that xPONENT works, for graphical user interface preferences.
LIS Settings This setting is only for those using xPONENT with a Lab Information System (LIS). Connect to LIS - Enables connection the LIS. Browse - Opens the Browse for Folder dialog box. Select a location for the system to watch for incoming orders. Arrange Main Navigation buttons These options enable you to rearrange the main page headers at the top of the xPONENT window. Arrange Main Navigation Buttons - Select or clear the check boxes to display or remove main page headers.
FIGURE 39. Group Setup Tab Users are assigned to groups. These users then have permissions granted to their group. Do not assign permissions directly to an individual user. On this tab, you can reinstate users who lock themselves out of the system at the System Login tab. This tab contains the following: Group Profile - The following user groups are predefined. • Administrator • Supervisor • Service • Technician2 • Technician1 • Reviewer The user will belong to the group you select.
The Allowed check box next to the desired permission in the Features section enables the selected group to perform that task. The Signature Required check box next to the desired permission requires a digital signature whenever a user in the selected group performs that task. Clear Allow and select Signature Required to require the electronic signature of another user whose account is configured to allow the action.
Archiving • Backup/Restore • Import/Archive When you perform an action that requires an electronic signature, the Electronic Signature dialog box opens. The user ID autopopulates. Type your password and any comments. Click OK to complete the electronic signature, or Cancel to cancel the signature. Cancel - Cancels changes Save - Saves changes. User Setup Tab Use this tab to create or edit a user account, remove a user from the system, or view a list of authorized users, along with their profile details.
FIGURE 41. Create User Account Screen This tab contains the following: User ID - Type a user ID in this box. The user ID is not case-sensitive. You can change the required number of characters on the User Setup tab. Once you create and delete a user ID, you cannot use that user ID again in the future. User - Type the user’s name. Account Status check box - Select this check box to lock the account. Clear this check box to unlock the account. When an account is locked, the check box is selected.
• Minimum User ID Length - The default minimum User ID length is six characters. • Minimum Password Length - The default minimum password length is six characters. Users - Displays a list of all users. The list includes ID, Name, and Profile information, and indicates whether or not a user account is locked. Delete User - Removes a selected user from the list. Edit User - Opens the Edit User Account screen. This screen has the same options as the Create User Account screen.
• Delta Cal Temp Exceeded Tolerance During Batch - The delta cal temperature fell outside the designated range during the running of the batch. Select the appropriate check boxes to display a pop-up message, send an email, or play a sound to alert you when the event occurs. All check boxes are selected by default. Cancel and Save buttons display if you change a setting. Speakers Attached/Speakers Not Attached - Enables sounds to be played through speakers.
Use US regionalization format only - Exports data only in US regionalization format. Include Advanced Statistics - Exports advanced statistics in the CSV file. CSV Export Folder and Automatically Exported Batch File - Displays the path and location where the CSV file or automatically exported batch file will be exported. Click Browse to change the file export location.
• Exclude Raw Data Files - Select this option if you have selected Batches in the File Type list to exclude files that contain only raw data. • Browse - Chooses the network or local PC destination folder for the exported archive file. The selected file displays in the Archive file export folder box. NOTE: Files are restored from the path displayed in the Archive file export folder box. Use the Browse button to select the file path if necessary.
FIGURE 45. Licensing Tab This tab contains the following: License Code - The current license code being used on the system. Current License Agreements - You cannot start the software unless the license agreements are accepted. Therefore, the current license agreements will always display as Accepted. Status - Displays the status of the licensing agreements. Export - Opens the Save As dialog box to select an export name and location. License - Opens the Change License dialog box.
FIGURE 46. Schedule Tab Reminders - This section displays reminders for scheduled maintenance. • Alert Time - Select a time from this list to display maintenance reminders. • Recurrence - Select Daily, Weekly, Bi-Weekly, Monthly, Bi-Annually, or Yearly recurring reminders from this list. • Enabled - Select or clear this check box to enable or disable the reminders. Cancel - Cancels changes. Save - Saves changes. xPONENT® 3.1 Rev.
Chapter 3: Using the Software This chapter describes the steps needed to successfully use the xPONENT software. Starting the Software When you turn on the computer for your Luminex system, xPONENT® should launch automatically. If it does not, click the Luminex xPONENT icon on the PC desktop, or click Start > Programs > Luminex > xPONENT > Luminex xPONENT. If you have a trial license, a dialog box opens. Click OK to close the dialog box.
Setting Administrative Options Click Admin on the toolbar to display the tabs used to set administrative options. System Setup You must have xPONENT administrative privileges to perform System Setup tasks. Application Settings Use Application Settings to define how the software runs and displays. 1. Select the options you want to enable in the software. For a description of each option, see the Application Settings section. 2. Click Save.
The data conversion utility is xCONVERT. For additional information about using the xCONVERT utility, see the Appendix A: Converting IS 2.3 .idt Files to xPONENT 3.1 .lxt Files section. Group Setup You must have xPONENT administrative privileges and be using the Secure package of the software to perform group setup tasks. Additionally, you must have the 21 CFR Part 11 package to require electronic signatures. 1. In the Group Profile list, click the group profile you want to set up. 2.
Editing User Permissions In the Users list, click the user ID, then click Edit User. In the Edit User Account screen, edit the desired information, then click Save. Restoring Account Status If users attempt to log in unsuccessfully more than the number of times allowed, they will be locked out. In the User list, click the user ID, then click Edit User. Clear the Account status: Locked check box, then click Save. Alert Options To set notification options about various system events: 1.
Archive Use the settings on the Archive tab to set options for backing up, exporting and restoring files. To archive a file: 1. In the File Type list, click the file type you want to archive. 2. Click the files you want to archive in the list below the Archive Folder box (this list displays all files of the selected file type in the internal database). 3. In the Archive Folder box, verify the location to which you want to archive the file.
3. Click OK to start the restore. A progress bar displays, followed by a Warning dialog box stating that xPONENT needs to be restarted. 4. Click OK to restart xPONENT. Licensing You can use the functions on the Licensing tab to change your license information if you are upgrading to a different software package (from Basic to Secure, for example). If you are using a trial license and it has expired, contact Luminex technical support. To obtain a new license: 1. Click Export.
2. Review the adjustment location for the well that you will use for alignment. Click a well on the plate image if you want to use a different well. A blue pin notes the well selected for alignment. 3. Remove the clear plastic shield that covers the sample probe area. 4. In a 96-well microtiter plate where overall height is no more than 0.75 inches (19mm), place the appropriate alignment tool in the plate: • For a standard plate with flat bottom wells - stack two of the larger (5.
• Open the Maintenance page, and then the Cmds & Routines tab. Click Warmup in the Commands section at the left of the screen, and then click the Run button at the bottom right to begin the procedure. The warmup process takes 30 minutes to complete. Calibrator xMAP beads are used to normalize the settings for the reporter channel, both classification channels, and the doublet discriminator channel. Verification xMAP beads are used to verify calibration and optical integrity of the system.
WARNING: Inaccurate data entry can invalidate the results of these procedures. Careful entry of data in each field is necessary to ensure accurate results. 1. On the Home page, click System Initialization. 2. Click Import Kit at the bottom right side of the window. The Import Calibration or Performance Kit dialog box opens. 3. Locate the xMAP calibrator or verification kit information file (.lxl) and click Open. Import CAL or VER Kits 1. Open the Maintenance page, then open the Lot Management tab.
8. Click Print to print the report, or Save to save the report. 9. Click New Report to generate another report. Managing Sample Lists Use the Samples page to create a sample list, view or edit sample list details, or create a batch. Create New Sample List 1. Open the Samples page. 2. In the Sample Lists section, select the protocol you are using for the sample list, then click Create New Samples. The Create Sample tab opens. 3. In the ID box, type the sample ID 4.
You can group batches together as a multi-batch. Multi-batches can consist of any number of batches that have been set up from different protocols and are processed consecutively. Multi-batches can only be run on one plate. Protocols are provided on CD as part of your assay kit. Protocols typically include assay standards, controls, and maintenance commands (such as washes or primes to acquire along with samples). Assay reagents are included in assay kits.
1. Open the Batches page. 2. Click Create a New Batch from a new Protocol to open the Settings tab. 3. Type a name in the Name box. 4. Type a description in the Description box. 5. Define the settings in the Acquisition Settings section. NOTE: For information about each of these settings, see the Settings Tab section. 6. Define the settings in the Analysis Settings section. For more information about each of these settings, see the Analysis Settings information within the Settings Tab section.
well command. If you are working with more than one plate, choose the Plate list. Here, you can add a plate, change the order of the plates, and scroll through all plates • As you add commands to your plate, they appear in the Command Sequence list. Here you can give each of your wells an ID. You can also import an ID list and move your commands up and down to change the order in which they will be acquired. For additional information, see the Plate Layout Tab section. 17.
Import Batch You need to import batches to the system only once. You must type lot information for the standard and control reagents as specified in the protocol. This lot information is used for every batch setup using the protocol until it is changed. 1. Open the Batches page. 2. Click Import. The Import Batch dialog box opens. 3. Click Browse to open the Select File dialog box. Navigate to the batch file you want to import, then click Open. 4. Click OK in the Import Batch dialog box.
NOTE: You cannot delete or edit a batch included in a saved multi-batch. Remove the batch from the multibatch to make changes. Run Batch Open the Batches page. Select the pending batch that you want to run, then click Run. NOTE: If the batch spans more than one plate, the tray ejects automatically when all defined wells have been acquired. A dialog box displays prompting you to insert the next plate.
Performing Analysis You may direct the system to acquire samples in replicate regardless of batch type. For qualitative batches, qualitative results for replicates are averaged and the reported interpretation is determined from this replicate average. Analyze Current Batch When you run a batch, the Current Batch tab opens. Here, you can view real-time analysis of acquired analytes. To view a single statistic type for all analytes click the statistic you want to view from the Statistic list.
are working with more than one plate, choose the Add & Change Plate drop down list. Here, you can add a plate, change the order of the plates, and scroll through all plates. • As you add commands to your plate, they appear in the command sequence list. Here, you can give each of your wells an ID. You can also import an ID list and move your commands up and down in the command sequence chart. NOTE: Only wells that were acquired in the original batch can be replayed. 10. Click Replay Batch.
View Sample Details 1. Open the Results page and then open the Saved Batches tab. 2. Click Saved Batches, then click the batch for which you want to view details. 3. Click Open, then click Sample Details. The Sample Details tab opens. If you are using an LIS licensed package of the software, click Transmit to transmit sample details to the LIS database. You can transmit either a single analyte per sample or the entire sample.
Import Protocol 1. Open the Protocols page, then open the Protocols tab. Click Import. 2. In the Open dialog box, navigate to the protocol file you want to import, then click Open. 3. The imported protocol displays in the Installed Protocols list. Add New Lot for Protocol 1. Open the Protocols page, then open the Protocols tab. Click the protocol to which you want to add a lot. 2. Open the Stds & Ctrls tab. 3.
For assay reagents specified in protocols, you can create new lots, edit lot information, select pre-existing lots for reuse, import lots, and export lots. Assay kits include standards and/or controls. Once you enter the assay kit information, it can be used in multiple protocols. However, you should create separate kits specific for use with each protocol. Create Kit 1. Open the Protocols page, then open the Protocols tab. 2.
Delete Lot 1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab. 2. In the Installed Kits And Lots section, click the lot you want to delete, then click Delete. Export Lot NOTE: Lots and kits can only be exported if the protocol they were originally created with exists within the system (i.e. if the protocol has been deleted, the lot or kit cannot be exported). 1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab. 2.
with the Luminex analyzer operations and maintenance requirements. See the Luminex System Manual for more information. 1. Open the Maintenance page, then open the Cmds & Routines tab. 2. In the Routine Name list, click None. 3. In the Commands section, click one or more commands to add to the routine. These commands display in the plate image and in the Command Sequence list. 4.
Delete Routine You can delete a routine that you created, but you cannot delete predefined routines. Predefined routines have (Luminex) after the routine name. On the Cmds & Routines tab of the Maintenance page, click the routine that you want to delete from the Routine Name list, then click Delete. Import Routine On the Cmds & Routines tab of the Maintenance page, click Import. In the Open dialog box, browse for the routine file (.lxd) you want to import, then click Open.
4. Click Run. Logging Out of the Software To log out of xPONENT, click the Log Off icon in the upper right corner of the software window. The Confirm Logout dialog box opens. Click OK. NOTE: This only logs you out of the software; it does not exit the software. Exiting the Software Log out of the software. The System Log-in page displays. Click the Exit tab, then click Yes.
Appendix A: Glossary Term Definition 21 CFR Part 11 21 CFR Part 11 sets the criteria under which the Food and Drug Administration (FDA) considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. agglutination The coalescing of small particles that are suspended in solution; these larger masses are then (usually) precipitated.
TABLE . Continued Term Definition bead map A collection of bead sets with defined classification coordinates. bead set A set of xMAP microspheres that have a uniquely identifiable ratio of two classification dyes. The unique ratio is identified by a unique spectral address. Also sometimes called microsphere set, microsphere region, or test by the software during acquisition.
TABLE . Continued Term Definition dot plot Graphical representation of microsphere analysis classification data displayed by frequency and intensity. doublet discriminator (DD) A classification channel measuring side scatter; used to filter for single bead events based on size. emission spectrum Wavelength range that an excited fluorochrome emits when its electrons fall from a higher to a lower energy state. Expressed in nanometers (nm).
TABLE . Continued Term Definition microparticle A solid substance with a diameter in the micrometer range. Often used as a synonym for a microsphere. microspheres Polystyrene spheres with a diameter in the micrometer range. Also called beads. multi-analyte Several assays or tests performed simultaneously in the same reaction container. multi-batch A set of batches to be processed consecutively on a single plate.
TABLE . Continued Term Definition reporter A molecule (or combination of molecules) with a specific range of excitation and emission wavelengths that is used to identify or quantify an analyte. Examples of acceptable reporters are Phycoerythrin and Alexa 532. Reporter signals are the final result of each assay. reporter channel (RP or RP1) A specific range of wavelengths that includes the emission wavelength of a designated reporter molecule. RP See reporter channel.
TABLE . Continued Term Definition Verifier microspheres, assay Used to verify standards within the kit. Tells you that the curve or thresholds are correct. Verifier microspheres, system xMAP microspheres used to verify the calibration and optical integrity for the Luminex analyzer. xMAP See Luminex xMAP microsphere set. xPONENT® 3.1 Rev.
